1+ months

Clinical Research Specialist

Canberra, ACT 2617
Clinical Research Specialist


Macquarie Park, New South Wales, Australia

Requisition #:


Post Date:

Jan 22, 2020

**Careers that Change Lives**

Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. Are you looking for the opportunity to be on the cutting edge of medical devices clinical research?

**A Day in the Life**

A new opportunity exists for a Clinical Research Specialist to join our Cardiac Vascular Group Clinical division. Reporting to the Clinical Research Manager, this is a unique opportunity to join a highly skilled team of Clinical Research professionals executing on an innovative portfolio of cardiovascular device research. You will be an experienced Clinical Research Associate or Clinical Research Specialist, with proven monitoring experience within medical devices/ Pharma or CRO. It is expected that you will be undertaking monitoring across Perth and it is a wonderful opportunity over time, to take your monitoring career towards project management in medical technology and device research.

**Key accountabilities:**

+ Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies.

+ Assist in preparation of sections of the Investigational Plan for assigned clinical studies.

+ Assist in preparation of study materials and/or training (e.g., training of investigators, site staff and Medtronic field staff).

+ Interface with, and assure training of investigators, site staff, and Medtronic clinical staff.

+ Conduct site initiation (e.g. start-up document preparation, distribution, receipt, and review). Set-up and maintain accurate study status and implant logs.

+ Conduct site monitoring

+ Interfaces with representatives from key functional groups (Research Development, Manufacturing, Sales, Marketing, Regulatory Affairs, and European Clinical Groups).

+ Assist in preparation of study budget and project plans.

+ May arrange conference calls, staff meetings and training events.

+ Assist in compilation and review of adverse event information.

+ Assist in follow-up and resolution of site issues noted by field staff.

+ Assist in compilation, review and conclusion of device complaints.

+ Assist in study closure activities (e.g. close-out document preparation, distribution, receipt and review, audit and archive).

+ Assist data management group with review of clinical data/information and oversight of data correction.

+ Assist in preparation of annual, interim and final reports and presentations.

+ Assist in control of device allocation, distribution and reconciliation.

+ May provide oversight of activities performed by Contract Research Organizations (e.g. CROs, core labs).

+ May provide work direction to Associated Clinical Research Specialist(s).

+ Able to refer to Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs) for guidance on everyday study tasks.

+ Contribute to ongoing SOP development and review.

+ Participate in training to enhance knowledge base.

+ Ensure a safe working environment in accordance with the relevant Occupational Heath and Safety (OHS) legislation.

+ Work within and actively promote Medtronics core mission, corporate strategies, policies, procedures and Code of Conduct.

+ Observe all health and safety policies and procedures and take all reasonable care that actions or omissions do not impact on the health and safety of others.

+ Work within and actively promote Medtronics Mission, corporate strategies, policies, procedures and Code of Conduct.

+ Comply with Medtronics Finance and Legal policies and procedures, respond to both Internal and External Audit enquiries in a timely manner, and ensure follow-up on Action Items to address Audit recommendations.

**Must Have:**

+ Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.

+ Minimum 3-5 years experience directly supporting clinical research or relevant experience in medical/scientific area.

+ Fluency in English (additional language skills in Mandarin, Cantonese, Malay or Thai preferred)

+ Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology.

+ Computer literacy including sound knowledge of the MS Office suite of software.

+ High attention to detail and accuracy.

+ Ability to manage multiple tasks.

+ Good prioritization and organizational skills.

+ Excellent problem-solving skills

+ Flexibility, positive and dependable.

+ The ability to works effectively within cross-functional teams.

+ A professional manner and appearance.

+ Bachelors degree qualifications (technical or non-technical). Technical degree defined as engineering, life sciences or a related medical/scientific field.

**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


Posted: 2020-01-24 Expires: 2020-03-01

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Clinical Research Specialist

Canberra, ACT 2617

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